# Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 53/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260857 |
| Device | Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set |
| Applicant | Sol-Millennium Medical, Inc. |
| Specialty / panel | Clinical Chemistry |
| Product code | JKA |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-03-16 |
| Decision date | 2026-10-21 |
| Review time (days) | 219 |
| Third-party review | No |
| Applicant location | Chicago, IL, US |

## Why this score
- 219-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260857). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.